ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

Inclusion Criteria:

• Men and women, age 30 years and older
• Subjects who are able and willing to give informed consent and able to attend all study visits
• Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
• Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
• Subject exhibits a significant disability from their PD tremor despite medical treatment
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
• Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria:

• Subjects with unstable cardiac status
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
• Severe hypertension
• Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
• Significant claustrophobia that cannot be managed with mild medication
• Current medical condition resulting in abnormal bleeding and/or coagulopathy
• Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
• History of intracranial hemorrhage
• History of multiple strokes, or a stroke within past 6 months
• Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
• Are participating or have participated in another clinical trial in the last 30 days
• Subjects unable to communicate with the investigator and staff
• Subjects with a history of seizures within the past year
• Subjects with brain tumors
• Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
• Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia